Is this your brand? Sign in to claim ownership.

ZEUS SCIENTIFIC, INC.

United States·US-MF-000026845

Last updated May 23, 2026

What ZEUS SCIENTIFIC, INC. makes

Zeus Scientific, Inc. manufactures in vitro diagnostic (IVD) test kits for detecting specific antibodies and biomarkers in blood or serum. These include enzyme immunoassays (EIA) for Borrelia burgdorferi, Helicobacter pylori, herpes simplex viruses (HSV1/HSV2), and collagen-related markers, as well as fluorescent immunoassays for systemic lupus erythematosus (SLE)-associated antibodies, Epstein-Barr virus (EBV), and varicella-zoster virus (VZV). The portfolio also covers tests for autoimmune markers like anticardiolipin antibodies and anti-neutrophil cytoplasmic antibodies (ANCA).

The company’s products are regulated under FDA Class I and Class II devices, with submissions recorded in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These tests are designed for laboratory use in diagnosing infectious diseases, autoimmune conditions, and other medical evaluations. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 200 Evans Way, Branchburg, United States
Website: www.zeusscientific.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-908-526-3744
PRRC Contact: Kevin Bielski
EUDAMED SRN: US-MF-000026845
FDA FEI Number: —
DUNS Number: 080953946

Catalogue (338)

Page 6 of 7

Device	Model / Reference	Registries	Class	Status
The Aptus (automated) Application Of The Gliadin Igg Elisa Test System.	K993250	FDA 510(k)	Class II	Active
Epstein-Barr Virus Capsid Antigen Anti	K811262	FDA 510(k)	Class I	Active
Zeus Scientific, Inc. Anti-Cardiolipin Igg Elisa Test System	K981014	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Toxoplasma Igg Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa)f	K984317	FDA 510(k)	Class II	Active
Ena Screen Elisa Test System	K941014	FDA 510(k)	Class II	Active
Test, (ivdp) Smoothmuscle Antibody	K760156	FDA 510(k)	Class II	Active
Modification To Zeus Scientific, Inc., Thyroglobulin Igg Elisa Test System	K000363	FDA 510(k)	Class II	Active
Rf Igm Elisa Test System	K961277	FDA 510(k)	Class II	Active
Anti-Skin Antibody Test System	K811261	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Hsv-1 Igg Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For	K984135	FDA 510(k)	Class II	Active
Alegria Flash CTD Screen	K250666	FDA 510(k)	Class II	Active
Toxoplasma Igm Elisa Test System	K913787	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Ebv-Vca Igm Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) Fo	K983801	FDA 510(k)	Class I	Active
Ebv-Vca-Igm Ifa Test System	K833014	FDA 510(k)	Class I	Active
Mycoplasma Slurry And Mycoplasma Crowntitre Ifa Test System	K946373	FDA 510(k)	Class I	Active
Athena Multi-Lyte Hsv 1 & 2 Igg Test System	K072178	FDA 510(k)	Class II	Active
Extractable Nuclear Antigen Assay	K840221	FDA 510(k)	Class II	Active
Zeus Anti-Cardiolipin Igs Elisa Test System	K981020	FDA 510(k)	Class II	Active
Zorba(tm) Igg Removal Reagent	K924197	FDA 510(k)	Class II	Active
Mycoplasma Igg Elisa Test System	K970150	FDA 510(k)	Class I	Active
ZEUS IFA(TM) nDNA Test System, ZEUS dIFine	K231616	FDA 510(k)	Class II	Active
Athena Multi-Lite Rheumatoid Factor Igm Test System	K033802	FDA 510(k)	Class II	Active
Modification To Zeus Scientific's Athena Multi-Lyte Ana Test System	K021103	FDA 510(k)	Class II	Active
Myeloperoxidase Elisa Test System	K964446	FDA 510(k)	Class II	Active
Gliadin Igg Elisa Test System	K990204	FDA 510(k)	Class II	Active
Ebv-Vca Igm Elisa Test Ststem	K944449	FDA 510(k)	Class I	Active
Test Sys. For Ndna Antibody Determ.	K780178	FDA 510(k)	Class II	Active
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit	K230863	FDA 510(k)	Class II	Active
Borrelia Burgdorferi Igm Western Blot Test System	K991185	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Rubella Igg Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) Fo	K983805	FDA 510(k)	Class II	Active
Legionella Elisa Test System	K970149	FDA 510(k)	Class II	Active
Cmv Elisa Test System	K924096	FDA 510(k)	Class II	Active
Epstein-Barr Virus Early Antigen (ea) Antibody Tes	K882447	FDA 510(k)	Class I	Active
Modification To Zeus Scientific, Inc., Tpo Igg Elisa Test System	K000362	FDA 510(k)	Class II	Active
Autoantibody Screen Test System	K831358	FDA 510(k)	Class II	Active
Fta-Abs Test System	K781403	FDA 510(k)	Class II	Active
Zeus Scientific, Inc Vzv Igm Elisa Test System	K070317	FDA 510(k)	Class II	Active
Mycoplasma Igm Elisa Test System	K971503	FDA 510(k)	Class I	Active
Varicella-Zoster(igg) Ifa Test	K841434	FDA 510(k)	Class II	Active
Hsv-1 And/Or -2 Igm Elisa Test System	K983656	FDA 510(k)	Class II	Active
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System	K191398	FDA 510(k)	Class II	Active
Athena Multi-Lyte Ana-Ii Test System	K042416	FDA 510(k)	Class II	Active
Ifa Test For Antibodies To Borrelia Burgdorferi	K871246	FDA 510(k)	Class II	Active
Alegria Flash ENA Screen	K250408	FDA 510(k)	Class II	Active
The Aptus (automated Application Of The Tpo Igg Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For The	K000880	FDA 510(k)	Class II	Active
Gliadin Iga Elisa Test System	K990207	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Scl-70 Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For The	K983423	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Anti-Cardiolipin Igm Elisa Test System	K984175	FDA 510(k)	Class II	Active
Zeus Scientific, Inc. Treponema Pallidum Igg Test System	K102283	FDA 510(k)	Class II	Active
The Aptus (automated) Application Of The Sm/Rnp Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For The	K983465	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (12)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Zeus Scientific, Inc. has 12 FDA recall records initiated between February 24, 2000, and October 31, 2023. The records reflect a mix of open, classified, and terminated statuses, with reasons including issues such as bacterial contamination, incorrect calibrator values, false positives due to programming errors or reactivity loss, mislabeled controls, and unapproved product modifications. Some recalls involved errors in packaging or labeling, while others cited deviations in optical density specifications or assay performance.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Oct 31, 2023	Z-0603-2024	—	open, classified	The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation.
Oct 31, 2023	Z-0602-2024	—	open, classified	The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation.
Aug 12, 2019	Z-3026-2020	—	terminated	FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA Test System, the firm assigned a new Correction Factor and new lot number to the remainder of the affected lot, and distributed the reworked product to the customer.
Jul 22, 2019	Z-2494-2019	—	terminated	Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error results in well H6 being skipped for the addition of the TMB substrate. Well H6 will generate a negative result regardless of whether the patient was negative or positive for that antibody. This could result in a potential false negative result for that assay for any patients tested in well H6.
Mar 8, 2012	Z-1500-2012	—	terminated	Select lots of AtheNA Multi-Lyte MMV Test System have lost reactivity and may produce false positive results in seronegative patients who have not been previously affected with or vaccinated against Mumps.
Aug 19, 2008	Z-1089-2009	—	terminated	The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator Value (CV) printed on the label is 102; the correct CV should read 266.
Aug 30, 2004	Z-0214-05	—	terminated	During packaging, Lyme plates were packaged in this kit in error.
Jun 12, 2003	Z-1095-03	—	terminated	The Calibrator included within the kit may be losing reactivity.
Nov 9, 2001	Z-1031-03	—	terminated	Calibrator C not meeting its optical density specification.
Jun 22, 2001	Z-1147-03	—	terminated	Bacterial contamination of the high positive control.
Mar 19, 2001	Z-0961-03	—	terminated	Mix-up between low positive and negative controls.
Feb 24, 2000	Z-1065-03	—	terminated	The high positive control/low positive standard ratio recovering too low.